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NCT02330419 · ClinicalTrials.gov registry record · Phase 2
Better Than Study: Targeting Heavy Alcohol Use With Naltrexone Among Men Who Have Sex With Men (MSM)
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT02330419: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT02330419 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02330419, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
This is a double-blind, placebo-controlled trial of 120 binge-drinking MSM to 12 weeks of naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethnically and racially diverse participants will be recruited using Respondent Driven Sampling as well as active field recruitment. MSM will be seen weekly for alcohol-metabolite urine testing, study drug dispensing, and brief counseling for alcohol use. Safety assessments and behavioral surveys will be completed monthly.
Primary Outcome
This outcome measure determines the mean number of binge drinking days among participants randomized to targeted naltrexone and placebo arms. The Center for Disease Control (CDC) defines binge drinking as consuming 5 or more drinks on an occasion for men or 4 or more drinks on an occasion for women.
Interventions
- DRUG Placebo
- DRUG Naltrexone
- BEHAVIORAL Medical Management (MM) counseling for alcohol use:
- DIAGNOSTIC_TEST Urinalysis for novel alcohol biochemical markers:
- BEHAVIORAL Behavioral survey measurements:
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2015-04 |
| Est. Completion | 2021-01 |
| Phase | Phase 2 |
What the finished NCT02330419 record still lists
NCT02330419 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02330419 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02330419 about?
NCT02330419 is a clinical study titled "Better Than Study: Targeting Heavy Alcohol Use With Naltrexone Among Men Who Have Sex With Men (MSM)". This is a double-blind, placebo-controlled trial of 120 binge-drinking MSM to 12 weeks of naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethnically and racially diverse participants will be recruited using Respondent Driven Sampling as well as active field recruitment. MSM will be s...
What is the current status of trial NCT02330419?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2015-04. Estimated completion is 2021-01.
What interventions are being tested in trial NCT02330419?
The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG), Medical Management (MM) counseling for alcohol use: (BEHAVIORAL), Urinalysis for novel alcohol biochemical markers: (DIAGNOSTIC_TEST), Behavioral survey measurements: (BEHAVIORAL).
Who is sponsoring clinical trial NCT02330419?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02330419's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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